EFFERDENT ORIGINAL 102CT TAB 6 10814832015876Recalls & reported problems
Medtech Products Inc. · EFFERDENT ORIGINAL 102CT TAB 6 · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814832015879), received between Oct 4, 2021 and Oct 4, 2021.
The most frequently reported specific device problem is “Labelling, Instructions for Use or Training Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Labelling, Instructions for Use or Training Problem1
- Patient Device Interaction Problem1
Patient problems
- Inflammation1
- Skin Inflammation/ Irritation1
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
Oct 4, 2021Labelling, Instructions for Use or Training Problem; Patient Device Interaction Problem
PRODUCT: EFFERDENT ESSENTIAL CLEAN 5-IN-1 CLEANSING SYSTEM TABLETS- ON 07/15/2021, A COMPLAINANT CALLED TO REPORT SHE IS CONCERNED THAT THE INGREDIENT LIST IS NOT ON THE PRODUCT CONTAINER. SHE ALSO STATED SHE DID NOT SEE THE INGREDIENT LIST ON THE COMPANY WEBSITE. COMPLAINANT LATER ALSO REPORTED SHE USED THE PRODUCT ON A MONDAY AND NOTICED HER LIPS BECAME INFLAMED. A FEW DAYS LATER, SHE THEN TESTED THE PRODUCT ON HER ARM AND NOTICED WELTS WITHIN SIX HOURS. COMPLAINANT IS UNSURE OF THE EXACT DATES. COMPLAINANT WAS SEEN AT (B)(6) IN (B)(6) FOR HER INFLAMED LIPS. COMPLAINANT HAD NOT YET TESTED THE PRODUCT ON HER ARM AT THAT TIME. COMPLAINANT DOES NOT HAVE THE OUTER PRODUCT BOX AS ONLY A PRODUCT BLISTER PACK WAS GIVEN TO HER BY A FRIEND. HOWEVER, SHE PROVIDED THE LOT NUMBER AS 1483201587. COMPLAINANT CONTACTED THE FIRM WITH HER CONCERN. COMPLAINANT GAVE PERMISSION TO SHARE HER CONTACT INFORMATION. COMPLAINANT PROVIDED A PHOTO OF THE BACK LABEL AND STATED THAT HER FRIEND HAS NOT EXPERIENCED A PROBLEM WITH THIS PRODUCT. THIS PRODUCT IS CLASSIFIED AS A MEDICAL/DENTAL DEVICE PER:HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDRH/CFDOCS/CFCFR/CFRSEARCH.CFM?FR=872.3520. INJURY/ILLNESS: INFLAMED LIP
Patient problems: Inflammation; Skin Inflammation/ Irritation; Swelling/ Edema
MAUDE report 12576287 ↗
Other Cleanser, Denture, Over The Counter devices
- Cleaning Crystals, Packette 20127Align Technology, Inc. · Cleanser, Denture, Over The Counter3 reports
- Retainer Brite® RB-92Dentsply Sirona Orthodontics Inc. · Cleanser, Denture, Over The Counter1 report
- Retainer Brite® RB-36Dentsply Sirona Orthodontics Inc. · Cleanser, Denture, Over The Counter1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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